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Irbesartan in Type 2 Diabetes

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00317915
First Posted: April 25, 2006
Last Update Posted: April 25, 2006
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Bristol-Myers Squibb
Sanofi-Synthelabo
Information provided by:
Steno Diabetes Center
  Purpose
The aim of this multicenter, doubleblind, randomized study was to investigate the renoprotective effect of irbesartan treatment in patients with type 2 diabetes and microalbuminuria (a precursor of diabetic kidney disease). 590 patients were randomized to a median 24 months of treatment with 300 mg irbesartan once daily, 150 mg irbesartan once daily or placebo. Time to development of overt nephropathy, defined by persistent proteinuria, was the primary outcome measure.

Condition Intervention Phase
Type 2 Diabetes Microalbuminuria Hypertension Drug: Irbesartan treatment Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: The Irbesartan in Patients With Type 2 Diabetes and Microalbuminuria (IRMA 2)

Resource links provided by NLM:


Further study details as provided by Steno Diabetes Center:

Primary Outcome Measures:
  • Development of overt nephropathy

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Type 2 diabetes. Hypertension. Persistent microalbuminuria. Serum creatinine concentration of no more than 1.5 mg per deciliter (133 µmol per liter) for men and no more than 1.1 mg per deciliter (97 µmol per liter) for women. -

Exclusion Criteria:

Nondiabetic kidney disease. Cancer. Life-threatening disease with death expected to occur within two years. Indication for angiotensin-converting– enzyme (ACE) inhibitors or angiotensin-II–receptor antagonists. -

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00317915


Sponsors and Collaborators
Steno Diabetes Center
Bristol-Myers Squibb
Sanofi-Synthelabo
Investigators
Principal Investigator: Hans-Henrik Parving, Prof. DMsc Steno Diabetes Center
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00317915     History of Changes
Other Study ID Numbers: EFC2481
First Submitted: April 24, 2006
First Posted: April 25, 2006
Last Update Posted: April 25, 2006
Last Verified: April 2006

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Irbesartan
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action